(29 days)
Not Found
No
The summary describes a standard, qualitative immunoassay for detecting HCG in urine. There is no mention of AI, ML, image processing, or any computational analysis of the results. The performance studies are based on traditional analytical and clinical validation methods.
No.
The device is designed for the detection of pregnancy, which is a diagnostic purpose, not therapeutic.
Yes
This device is designed for the "qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy," which directly aids in diagnosing the state of pregnancy.
No
The device description explicitly states it is sold in three different formats (Cassette, Test Strip, and Midstream) and includes physical components like a test device, aluminum pouch, package insert, and a disposable plastic dropper. This indicates it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy." This involves testing a biological sample (urine) in vitro (outside the body) to provide diagnostic information (pregnancy status).
- Device Description: The device is designed to perform a test on a urine sample.
- Performance Studies: The performance studies described involve testing urine samples to evaluate the device's ability to detect hCG.
These characteristics align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CLUNGENE HCG Pregnancy Rapid Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
The CLUNGENE HCG Pregnancy Rapid Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
The CLUNGENE HCG Pregnancy Rapid Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
Clungene HCG Pregnancy Rapid Test will be sold in three different formats: Cassette, Test Strip, and Midstream. The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and a package insert. The Cassette format contains one test device, a disposable plastic dropper, and a package insert.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over the counter use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Analytical performance
a. Precision/Reproducibility/Sensitivity
Negative urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 12.5, 18.75, 22.5, 25, 50, 100 and 200mIU/mL. The spiked samples were measured in replicates using 3 different lots for each format. Tests were performed by three different operators for each sample concentration in 2 runs per day for 15 days.
Key results: The sensitivity of CLUNGENE HCG Pregnancy Rapid Test is demonstrated to be 25 mIU/mL.
c. Hook effect test:
Negative urine samples were spiked with varying hCG concentrations (62500, 125000, 250000, 500000, 1000000 and 2000000 mIU/mL). All tested concentrations gave a positive result.
Key results: No hook effect was observed at hCG concentrations ranging from 62500 to 2000,000 mIU/mL.
e. Specificity and cross reactivity
Negative and positive urine samples (10 mIU/mL and 25 mIU/mL) were spiked with various concentrations of glycoprotein hormones LH, FSH, TSH and hCG ß-core fragment.
Key results: No interference at 500 mIU/mL LH, 1000 mIU/mL FSH, 1000 mIU/L TSH and 2000,000 pmol/L hCG ß-core fragment for both negative and positive urine samples.
f. Interfering substance
To evaluate the potential for interference by certain exogenous compounds, each interfering substance was prepared by diluting stock interfering material to the desired concentration. Urine samples containing 10 mIU/mL and 25 mIU/mL hCG were spiked with the interfering substance to obtain the desired test concentration.
Key results: No interferences were observed from exogenous compounds at specified concentrations for both negative and positive hCG urine samples.
To evaluate potential interference from changes in pH, urine samples containing 10 mIU/mL and 25 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9.
Key results: Changes in pH range of 4~9 do not interfere in the results that were either positive or negative for hCG.
To evaluate potential interference from changes in specific gravity, urine samples containing 10 mIU/mL and 25 mIU/mL hCG were tested at density values ranging from 1.000 to 1.035.
Key results: Changes in specific gravity do not interfere in the results that were either positive or negative for hCG.
B. Method comparison study
Method comparison with predicate device
Study Type: Performance comparison with predicate device.
Sample size: 120 women presenting to test for pregnancy (approximately half suspected to be pregnant in early stage).
Data source: Urine samples collected from 120 women.
Annotation protocol: All samples were tested by three different health professionals for each format at 3 POC sites for a total of 12 POC operators with the proposed and the predicate devices.
Key results: The average positive conformity rate of Rapid Pregnancy Test is 100%. The average negative conformity rate of Rapid Pregnancy Test is 100%.
C. Lay person study:
Study Type: Lay person self-testing study.
Sample size: 300 women.
Data source: Urine samples from 300 women.
Annotation protocol: Each subject tested her own urine sample using the device according to the package insert and provided a sample for professional testing. Each lay person was given a questionnaire to assess the readability of the labeling.
Key results: The lay person results showed 100% positive and 100% negative conformity with the professional results. Consumers found the test easy to use and had no trouble understanding the labeling and interpreting the results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity: 25 mIU/mL
Method Comparison Study:
Strip Format: 100% positive conformity, 100% negative conformity.
Cassette Format: 100% positive conformity, 100% negative conformity.
Midstream Format: 100% positive conformity, 100% negative conformity.
Lay Person Study:
Strip: 100% positive conformity, 100% negative conformity with professional results.
Cassette: 100% positive conformity, 100% negative conformity with professional results.
Midstream: 100% positive conformity, 100% negative conformity with professional results.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
December 11, 2019
Hangzhou Clongene Biotech Co.,Ltd. % Joe Shia Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, Maryland 20877
Re: K193132
Trade/Device Name: CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: November 8, 2019 Received: November 12, 2019
Dear Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices | OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality CDRH | Food and Drug Administration
Enclosure
2
Indications for Use
510(k) Number (if known) K193132
Device Name
CLUNGENE HCG Pregnancy Rapid Test Cassette CLUNGENE HCG Pregnancy Rapid Test Strip CLUNGENE HCG Pregnancy Rapid Test Midstream
Indications for Use (Describe)
The CLUNGENE HCG Pregnancy Rapid Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
The CLUNGENE HCG Pregnancy Rapid Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
The CLUNGENE HCG Pregnancy Rapid Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K193132
510(k) SUMMARY
| 1. Date: | December 09, 2019 |
|---|---|
| 2. Submitter: | Hangzhou Clongene Biotech Co., Ltd. |
| 20 Longquan Road | |
| Hangzhou 311121, China | |
| Telephone: 86-571-88262120 | |
| Fax: 86-571-88261752 | |
| 3. Contact person: | Joe Shia |
| LSI International Inc. | |
| 504 East Diamond Ave., Suite J | |
| Gaithersburg, MD 20877 | |
| Telephone: 240-505-7880 | |
| Fax: 301-916-6213 | |
| Email:shiajl@yahoo.com | |
| 4. Device Name: | CLUNGENE HCG Pregnancy Rapid Test Cassette |
| CLUNGENE HCG Pregnancy Rapid Test Midstream | |
| CLUNGENE HCG Pregnancy Rapid Test Strip | |
| Classification: | Class II |
| Product Code | CFR # | Panel |
|---|---|---|
| LCX | 21 CFR, 862.1155 Human chorionic gonadotropin | |
| (hCG) Test System | Clinical | |
| Chemistry (75) |
-
- Predicate Devices: EGENS One Step HCG Urine Pregnancy Test (K123050)
6. Intended Use
CLUNGENE HCG Pregnancy Rapid Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
CLUNGENE HCG Pregnancy Rapid Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
CLUNGENE HCG Pregnancy Rapid Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
4
7. Device Description
Clungene HCG Pregnancy Rapid Test will be sold in three different formats: Cassette, Test Strip, and Midstream. The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and a package insert. The Cassette format contains one test device, a disposable plastic dropper, and a package insert.
| Similarities | ||
|---|---|---|
| Item | Candidate device | Predicate device K123050 |
| Intended use | Early detection of | |
| pregnancy | Early detection of | |
| pregnancy | ||
| Specimen | Urine | Urine |
| Assay technical | Immunochromatographic | |
| assay | Immunochromatographic | |
| assay | ||
| Sensitivity | 25 mIU/mL | 25 mIU/mL |
| Results | Qualitative | Qualitative |
| Target user | Over the counter use | Over the counter use |
| Device format | Strip, Cassette, Midstream | Strip, Cassette, Midstream |
| Differences | ||
| Item | Device | Predicate |
| Reading Time | 3 minute | 5 minute |
Substantial Equivalence Information 8.
Standard/Guidance Document Reference (if applicable) 9.
Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s, July 22, 2000
10. Test Principle
This device operates by detecting human chorionic gonadotropin (hCG), the hormone produced during pregnancy in urine, using a lateral flow sandwich immunochromatographic assay.
11. Performance Characteristics
A. Analytical performance
a. Precision/Reproducibility/Sensitivity
Negative urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 12.5, 18.75, 22.5, 25, 50, 100 and 200mIU/mL. The spiked samples were measured in replicates using 3 different lots for each format. Tests were performed by three different operators for each sample concentration in 2 runs per day for 15 days. The results are summarized in the table below:
5
Strip format
| hCG
Concentration
(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total result | | %
Negative | %
Positive |
|----------------------------------|-------|----|-------|----|-------|----|--------------|----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 22 | 8 | 25 | 5 | 25 | 5 | 72 | 18 | 80 | 20 |
| 22.5 | 13 | 17 | 14 | 16 | 17 | 13 | 44 | 46 | 48.9 | 51.1 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Cassette format
| hCG
Concentration
(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total result | | %
Negative | %
Positive |
|----------------------------------|-------|----|-------|----|-------|----|--------------|----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 25 | 5 | 24 | 6 | 24 | 6 | 73 | 17 | 81.1 | 18.9 |
| 22.5 | 15 | 15 | 13 | 17 | 13 | 17 | 41 | 49 | 45.6 | 54.4 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Midstream format
| hCG
Concentration
(mIU/mL) | | Lot 1 | | Lot 2 | | Lot 3 | | Total result | | %
Negative | %
Positive |
|----------------------------------|----|-------|----|-------|----|-------|----|--------------|------|---------------|---------------|
| | | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 | |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 | |
| 18.75 | 23 | 7 | 23 | 7 | 25 | 5 | 71 | 19 | 78.9 | 21.1 | |
| 22.5 | 16 | 14 | 17 | 13 | 14 | 16 | 47 | 43 | 52.2 | 47.8 | |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | |
Based on the above results, the sensitivity of CLUNGENE HCG Pregnancy Rapid Test is demonstrated to be 25 mIU/mL.
b. Linearity/assay reportable range:
6
Linearity is not applicable since this is a qualitative test.
c. Hook effect test:
Negative urine samples were spiked with varying hCG concentrations (62500, 125000, 250000, 500000, 1000000 and 2000000 mIU/mL). All tested concentrations gave a positive result. The results demonstrated that no hook effect was observed at hCG concentrations ranging from 62500 to 2000,000 mIU/mL.
d. Traceability, Stability, Expected values (controls, calibrators, or methods):
CLUNGENE HCG Pregnancy Rapid Test is calibrated against reference material traceable to WHO International Standard 5th edition.
A shelf-life stability test of the devices was performed by accelerated testing. The results showed that the devices were stable for 24 months when stored at 4~30℃ in the sealed foil pouch. Real time stability studies are ongoing.
e. Specificity and cross reactivity
To evaluate specificity and cross-reactivity, negative and positive urine samples (10 mIU/mL and 25 mIU/mL) were spiked with various concentrations of glycoprotein hormones LH, FSH, TSH and hCG ß-core fragment. The results showed that there is no interference at 500 mIU/mL LH, 1000 mIU/mL FSH, 1000 mIU/L TSH and 2000,000 pmol/L hCG ß-core fragment for both negative and positive urine samples.
f. Interfering substance
To evaluate the potential for interference by certain exogenous compounds, each interfering substance was prepared by diluting stock interfering material to the desired concentration. Urine samples containing 10 mIU/mL and 25 mIU/mL hCG were spiked with the interfering substance to obtain the desired test concentration. No interferences were observed from exogenous compounds at the following concentrations for both negative and positive hCG urine samples.
| Substances | Concentration |
|---|---|
| Acetaminophen | 20mg/dL |
| Acetoacetic Acid | 2000mg/dL |
| Asorbic Acid | 20mg/dL |
| B-hydroxybutyrate | 2000mg/dL |
| Caffeine | 20mg/dL |
| Ephedrine | 20mg/dL |
| Gentisic Acid | 20mg/dL |
| Phenylpropanolamine | 20mg/dL |
| Salicylic Acid | 20mg/dL |
| Phenothiazine | 20mg/dL |
| EDTA | 80mg/dL |
| Acetylsalicylic Acid | 20mg/dL |
| Benzoylecgonine | 10mg/dL |
| Cannabinol | 10mg/dL |
| Codeine | 6ug/dL |
| Ethanol | 1.0% |
| Methanol | 10% |
7
| Albumin | 2000mg/dL |
|---|---|
| Glucose | 2000mg/dL |
| Bilirubin | 2mg/dL |
| Atropine | 20mg/dL |
| Estriol-17-beta | 1400ug/dL |
| Hemoglobin | 500mg/dL |
| Pregnanediol | 1500ug/dL |
| Thiophene | 20mg/dL |
| Ampicillin | 20mg/dL |
| Tetracycline | 20mg/dL |
| Ketone | 20mg/dL |
To evaluate potential interference from changes in pH, urine samples containing 10 mIU/mL and 25 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9. The results indicated that changes in pH range of 4~9 do not interfere in the results that were either positive or negative for hCG.
To evaluate potential interference from changes in specific gravity, urine samples containing 10 mIU/mL and 25 mIU/mL hCG were tested at density values ranging from 1.000 to 1.035. The results indicated that changes in specific gravity do not interfere in the results that were either positive or negative for hCG.
B. Method comparison study
Method comparison with predicate device
The performance of the new device was compared to the predicate test. Urine samples were collected from 120 women presenting to test for pregnancy. Approximately half of the 120 women were suspected to be pregnant and most of them are in the early stage of less than 5 weeks. All samples were tested by three different health professionals for each format at the 3 POC sites for a total of 12 POC operators with the proposed and the predicate devices.
| Strip Format | Predicate device | ||
|---|---|---|---|
| Positive | Negative | ||
| CLUNGENE HCG® | |||
| Rapid Pregnancy Test | Positive | 63 | 0 |
| Negative | 0 | 57 |
| Predicate device | |||
|---|---|---|---|
| Cassette | Positive | Negative | |
| CLUNGENE HCG® | |||
| Rapid Pregnancy Test | Positive | 63 | 0 |
| Negative | 0 | 57 |
| Midstream | Predicate device | |
|---|---|---|
| Positive | Negative |
8
| CLUNGENE HCG®
| Rapid Pregnancy Test | Positive | 63 | 0 |
|---|---|---|---|
| Negative | 0 | 57 |
Conclusion from the above table:
The average positive conformity rate of Rapid Pregnancy Test is 100%. The average negative conformity rate of Rapid Pregnancy Test is 100%
C. Lay person study:
300 women's individual pregnancy status was self-tested, varying educational and occupational backgrounds from three sites were chosen for the study. Each subject tested her own urine sample using the device according to the package insert and provided a sample for professional testing.
Summary
| Rapid Pregnancy Test Strip | Professional | ||
|---|---|---|---|
| + | - | ||
| Lay person | + | 43 | 0 |
| - | 0 | 57 |
| Rapid Pregnancy Test Cassette | Professional | ||
|---|---|---|---|
| + | - | ||
| Lay person | + | 53 | 0 |
| - | 0 | 47 |
| Rapid Pregnancy Test Midstream | Professional | ||
|---|---|---|---|
| + | - | ||
| Lay person | + | 50 | 0 |
| - | 0 | 50 |
From the above tables, the lay person results showed 100% positive and 100% negative conformity with the professional results.
Each lay person was given a questionnaire to assess the readability of the labeling. The results of the questionnaire reflected that the consumers found the test easy to use and that they did not have trouble understanding the labeling and interpreting the results.
12. Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.